Anteris Reports $16.8M R&D Spend as PARADIGM Trial Gains FDA Approval
Anteris Technologies has gained FDA approval to start patient recruitment in the US for its pivotal PARADIGM Trial, following initial European regulatory success. The company advances manufacturing and clinical readiness as it pushes toward key regulatory milestones.
- FDA approval granted to commence US patient recruitment for PARADIGM Trial
- First patients treated in Denmark after European regulatory clearance
- Manufacturing scale-up and ISO 13485 certification underway
- Q3 R&D expenses total $16.8 million, reflecting trial preparation
- Company holds $9.1 million cash as of September 30, 2025
Regulatory Breakthroughs Propel PARADIGM Trial Forward
Anteris Technologies Global Corp. has marked a significant milestone in its journey to commercialize the DurAVR Transcatheter Heart Valve (THV) with FDA approval to begin patient recruitment in the United States for its pivotal PARADIGM Trial. This approval, announced in November 2025, follows the company’s earlier success in Europe, where the Danish Medicines Agency authorized the first patient treatments in October.
The PARADIGM Trial is a randomized controlled study designed to compare the safety and effectiveness of Anteris’ DurAVR THV against existing transcatheter aortic valve replacements (TAVRs). Enrolling approximately 1,000 patients across the US, Europe, and Canada, the trial aims to generate robust clinical evidence to support regulatory submissions for Premarket Approval (PMA) in the US and CE Mark certification in Europe.
Operational and Manufacturing Readiness Accelerate
Behind the scenes, Anteris has been intensifying efforts to scale up manufacturing capabilities and strengthen quality systems. The company is progressing toward ISO 13485 certification, a critical standard for medical device production, while expanding clean room capacity and cross-training personnel. These steps are essential to meet the anticipated demand generated by clinical activities and eventual commercial launch.
Financially, the company reported net operating cash outflows of $59.3 million for the first nine months of 2025, reflecting increased investment in clinical, regulatory, and manufacturing initiatives. Research and development expenses for the third quarter alone reached $16.8 million, underscoring the resource intensity of preparing for the PARADIGM Trial. Selling, general, and administrative expenses were $5.8 million, with cash reserves standing at $9.1 million as of September 30.
Strategic Positioning for Market Entry
CEO Wayne Paterson highlighted the critical nature of these recent developments, noting that regulatory approvals in both the US and Europe set the stage for the company’s activities through 2026. The DurAVR THV’s biomimetic design and patented anti-calcification tissue technology position it as a potentially transformative option for patients with aortic stenosis, a serious heart valve condition.
As Anteris moves into the next phase of clinical enrollment and data collection, the company’s ability to maintain operational momentum and secure further regulatory clearances will be closely watched by investors and industry observers alike.
Bottom Line?
With regulatory green lights in hand, Anteris is poised to prove its DurAVR valve’s clinical promise; but the path to market remains a high-stakes test.
Questions in the middle?
- How quickly will patient enrollment progress across multiple regions?
- What are the anticipated timelines for full trial completion and data readouts?
- Will Anteris secure additional funding to extend its cash runway beyond Q3 2025?
